Crestal vs Lateral Sinus Lift Augmentation

NCT04111250 | Completed

• 1 other identifier: iRaise_RCT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomised controlled trial (RCT) of split-mouth design was to compare patient preference and effectiveness of two different techniques for lifting the maxillary sinus: the crestal approach versus the lateral window approach.

Conditions

Edentulous Alveolar Ridge; Bone Atrophy, Alveolar

Keywords

Dental implants; Maxillary sinus augmentation; Crestal approach

Outcome Measures

Primary Outcomes (4)

• Prosthesis failure

  Planned prosthesis which could not be placed due to implant failure(s), loss of the prosthesis secondary to implant failure(s) or a prosthesis that had to be remade for any reasons.

  Up to 5 years

• Implant failure

  Implant mobility, removal of stable implants dictated by progressive marginal bone loss or infection, and implants fracture or any other mechanical complications rendering the implant unusable. The stability of each individual implant was measured with the removed prosthesis at abutment connection, at delivery definitive prostheses and at 1 year after loading, by tightening the implant abutment screws with a torque of 20 Ncm or by assessing the stability of individual crowns using the handles of two metallic instruments.

  Up to 5 years

• Complications

  Any technical and biological complications

  Up to 5 years

• Patient's preference (questionnaire)

  Answers: 1) the side treated with the crestal technique, 2) the side treated with the lateral technique, 3) none, both treatments were equally good, 4) none, both treatments were equally bad.

  Assessed 1 week and 1 month after surgery

Secondary Outcomes (2)

• Time (minutes)

  The time in minutes of the surgical procedure, from the incision of the gingiva to the placement of the last stitch

• Marginal bone loss

  1 year after loading

Study Arms (2)

Crestal sinus lift using iRasie implant

EXPERIMENTAL

Device: iRaise Sinus Lift implant (Maxillent, Herzliya, Israel). Procedure: crestal sinus lift augmentation. We tested crestal versus lateral approach to the sinus. Crestal approach is made by a novel device (iRaise, implant system). Lateral approach is made conventionally with gold standard procedure (lateral approach). The iRaise Sinus Lift implant is made of Titanium-6 Aluminum-4 Vanadium alloy, have a surface treated with grit blasting using an apatitic calcium phosphate media, followed by acid etching, and have an internal hexagon connection. Implants have an internal l-shape channel to allow saline and graft passage. This implants system is made to perform crestal sinus lift procedure at the same time of the implant placement using the same device. After implant site preparation and initial implant placement, the hydraulic system is connected to the implant to allow the injection of saline and then graft the material. Then, the implant, is inserted for its full length.

Procedure: Maxillary sinus augmentation

Lateral sinus lift

ACTIVE COMPARATOR

Conventional procedure. Lateral approach to the sinus was made following the conventional procedure. A window on the lateral wall of the sinus is performed according to a conventional surgical lateral approach to the sinus cavity. Graft materials is filled inside the sinus cavity. Finally, iSure implants \[Maxillent\] are placed, and flap is sutured.

Procedure: Maxillary sinus augmentation

Interventions

Maxillary sinus augmentation PROCEDURE

Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.

Also known as: Sinus lift

Crestal sinus lift using iRasie implant; Lateral sinus lift

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Partially edentulous patient
• Bilateral edentulism in posterior maxillae (premolars and molars)
• years or older
• Able to understand and sign an informed consent.
• At least 3 months after tooth extraction
• Vertical bone height at the implant sites between 2 to 6 mm
• Bone thickness at least 6 mm as measured on CBCT scan

You may not qualify if:

• general contraindications to implant surgery
• subjected to irradiation in the head and neck area
• immunosuppressed or immunocompromised
• treated or under treatment with intravenous amino-bisphosphonates
• poor oral hygiene and motivation
• untreated periodontal disease
• uncontrolled diabetes
• pregnant or lactating
• substance abusers
• psychiatric problems
• unrealistic expectations
• lack of opposite occluding dentition/prosthesis
• acute or chronic infection/inflammation
• augmentation/implant placement
• referred only for implant placement

Sponsors & Collaborators

• Hospital San Pietro Fatebenefratelli: lead

Study Sites (1)

Aldent University

Tirana, Albania

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Sinus Floor Augmentation

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Where possible, outcomes assessor was blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Split mouth design

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: October 1, 2019
• Study Start: November 1, 2015
• Primary Completion: March 30, 2018
• Study Completion: April 2, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

AL (1)